(110 days)
The MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only.
The MS System (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. MS System (Narrow Ridge) is intended for single use only. It is not for immediate load.
The MS System is a dental implant made of Ti-6Al-4V metal. The MS System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface treatment of MS System is R.B.M (Resorbable Blasting Media).
I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets them in the format requested.
The document is a 510(k) Summary for a dental implant system (MS System) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing specific performance acceptance criteria and a study to meet them.
Here's a breakdown of what is and is not in the provided text:
What is present:
- Device Name: MS System Dental Implant
- Intended Use: The text describes the intended use for two versions: MS System (Denture) and MS System (Narrow Ridge).
- Material: Ti-6Al-4V metal.
- Surface Treatment: R.B.M (Resorbable Blasting Media).
- Biocompatibility: Mentions biocompatibility tests were performed.
- Predicate Devices: K072959 (MS System (Denture)), K080594 (MS System (Narrow Ridge)), and K080129 (Secure Implant System).
What is NOT present in the provided text:
- A table of acceptance criteria and reported device performance: This document states that "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations" and that the "MS System has been subjected to safety, performance, and product validations prior to release." However, it does not provide specific quantitative acceptance criteria or the actual performance results against those criteria.
- Sample size used for the test set and data provenance: No information about a specific test set, its size, or where the data came from (country, retrospective/prospective).
- Number of experts and qualifications for ground truth: No mention of experts or their role in establishing ground truth for any test.
- Adjudication method for the test set: Not applicable as no test set with expert ground truth is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study would compare human reader performance with and without AI. Since the device is a dental implant, not an AI diagnostic tool, an MRMC study is not relevant and not mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device.
- Type of ground truth used: Not applicable as no specific performance study with ground truth is described.
- Sample size for the training set: Not applicable as this is a physical medical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The document concludes that the MS System is "safe and effective and substantially equivalent to the predicate device." This substantial equivalence is based on similar material, indication for use, design, and technological characteristics, as well as general safety and biocompatibility tests, but not a detailed performance study against specific acceptance criteria as you would typically see for a new diagnostic device or AI algorithm.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.